Silver Graft All Comers Registry

NCT01970605 | Completed DMC

• 1 other identifier: AAG-O-H-1310
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

This web based e-Registry will be international, multi-center and prospective. Silver Graft e-Registry to assess the long term clinical benefit of Silver Graft in an unselected patient population

Conditions

Aneurysm; Graft Failure; Graft Infection

Outcome Measures

Primary Outcomes (1)

• graft patency

  12-month patency assessed with duplex ultrasound

  12 months

Secondary Outcomes (1)

• Freedom from infection

  at 12 months

Other Outcomes (1)

• Freedom from perigraft fluid presence

  12 months

Study Arms (1)

Patients with PAOD or aneurysms

Patients * in Fontaine class \> IIa, * in need of aneurysm repair, * with defined cardiovascular risk factors or * graft infections. Surgical reconstruction with defined Silver Graft vascular prosthesis.

Procedure: Surgical reconstruction

Interventions

Surgical reconstruction PROCEDURE

In contrast to silver acetate impregnated vascular graft, Silver Graft can be immersed in an antibiotic containing solution prior to implantation. This practice should always be followed according to each participant's hospital guidelines and experience. The long term efficacy of the metallic silver coating will not be reduced. Common practice antibiotic co-medication before, during and after surgery needs to be documented but is at the discretion of each participating institution. Due to the registry character of this assessment, i.e. routine use of the investigational product, local antibiotics, e.g. dipping of the vascular graft into a rifampin solution is permissible.

Also known as: Vascular reconstruction, Vascular prosthesis, Silver Graft

Patients with PAOD or aneurysms

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with PAOD Fontaine classification \> IIa Patients in need of aneurysm repair Patients in need of revisions, i.e. graft infections

You may qualify if:

• Any suitable patient in need of an infrarenal vascular reconstruction with Fontaine class IIb or indicated vascular reconstruction aneurysm repair.
• Any suitable patient with an increased risk for early graft failure except those mentioned under (3). These may include
• diabetics
• Fontaine class\> IIb
• patients of advanced age (≥75 y)
• patients with renal insufficiency (creatinine ≥ 1.50 mg/dl or ≥130 µmol/l)
• patients with COPD or documented coronary artery disease (prior PCI, prior CABG, documented myocardial ischemia)
• patients with major amputation
• immunosuppressed patients
• patients with autoimmune disease, malignancy
• Any suitable patient with graft infection or present infection in the anatomical position of indicated vascular reconstruction.

You may not qualify if:

• Any patient with common contraindications for vascular surgery may not be included in this registry.
• Any patient with an estimated life expectancy less than the first follow-up period, i.e. 12 months is excluded from data entry.
• Any patient with a known and documented allergy to silver or silver ions.

Sponsors & Collaborators

• B. Braun Melsungen AG: lead

Study Sites (1)

Klinikum Magdeburg

Magdeburg, 39130, Germany

Location

Related Publications (2)

• Zegelman M, Guenther G, Waliszewski M, Pukacki F, Stanisic MG, Piquet P, Passon M, Halloul Z, Tautenhahn J, Claey L, Agostinho C, Simici D, Doebrich D, Mueller C, Balzer K. Results from the International Silver Graft Registry for high-risk patients treated with a metallic-silver impregnated vascular graft. Vascular. 2013 Jun;21(3):137-47. doi: 10.1177/1708538113478773.

  PMID: 23508393 BACKGROUND

• Zegelman M, Guenther G, Florek HJ, Orend KH, Zuehlke H, Liewald F, Storck M. Results from the first in man german pilot study of the silver graft, a vascular graft impregnated with metallic silver. Vascular. 2009 Jul-Aug;17(4):190-6. doi: 10.2310/6670.2009.00034.

  PMID: 19698298 BACKGROUND

MeSH Terms

Conditions

Aneurysm

Interventions

Blood Vessel Prosthesis

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Jörg Tautenhahn, MD

  Klinikum Magdeburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: October 28, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: January 23, 2019

Record last verified: 2019-01

Locations

DE (1)